RNXT RenovoRx, Inc.
$1.40
RenovoRx, Inc. Q2 F2026 Earnings Call Transcript
Wednesday, August 12, 2026
AI Conference Call Analysis
Sign in or subscribe to read.Conference Call Operator
Operator
Good afternoon. I will be your conference call operator today. Please note that today's call is being recorded, and all participants, other than management, are in listen-only mode. There will be a Q&A session following management's presentation. I will now turn the call over to Valter Pinto, Managing Director of KCSA Strategic Communications. Please go ahead.
Valter Pinto
Managing Director of KCSA Strategic Communications
Thank you, operator. Good afternoon and welcome everyone to the RenovoRx second quarter of 2026 financial results conference call. I'm joined today by members of our leadership team, including Shaun Bagai, chief executive officer, Dr. Ramtin Agah, chief medical officer, executive chair and founder, and Mark Voll, chief financial officer. Before we begin, I'd like to remind everyone that statements made during today's call contain or may contain forward-looking statements covered by the Safe Harbor Provisions of the Private Security Litigation Reform Act of 1995 and applicable federal securities laws. These statements, including statements regarding RenovoRx's clinical and commercial plans, strategies, and estimates, or expectations of financial or operational performance, including revenue, are based on management's current plans and assumptions, and actual results may differ materially. Please refer to our filings with the SEC, including our Form 10-Q for the quarter ended June 30th, 2026, for a detailed discussion of the risks and uncertainties facing Renovo Rx. With that, I now turn the call over to our Chief Executive Officer, Shaun Bagai.
Shaun Bagai
Chief Executive Officer
Thank you, Walter, and good afternoon, everyone. Over the past several quarters, we set out three milestones for Renovo Rx. In this quarter, we delivered on all three. First, revenue growth. The second quarter was a record revenue quarter, our strongest to date. Second, commercial momentum. We activated new commercial cancer centers at a pace ahead of our internal targets. And third, expansion beyond locally advanced pancreatic cancer. For the first time, a treating physician chose RenovoCAF to deliver therapy to a patient with a different solid tumor. We told our investors we were going to achieve these goals, and we delivered. Last quarter, we spoke openly about the meaningful progress we've made on the commercialization of RenovoCat, shifting our narrative from concept to execution and growth. This quarter shows our commercial execution in action with our highest quarterly revenue, and we could not be more excited about our future. Our job now is to keep delivering quarter after quarter. For the second quarter ended June 30, 2026, RenovoRx generated record revenue of $909,000, are strongest quarterly performance to date, increasing approximately 61% sequentially and approximately 115% year-over-year. To put this performance in perspective, our second quarter revenue alone represented approximately 83% of our entire full-year 2025 revenue of $1.1 million. This is the direct, measurable result of the commercial model we have described. More active commercial cancer center customers More procedures and more revenue. With each new center we activate adding to our growth and creating a compounding effect. Let's walk through our predictors of our future revenue. Revenue growth is the outcome, but the leading indicator of continued revenue growth in the coming quarters and the metric I would encourage investors to continue to watch most closely is new account activations. Our activated commercial cancer centers to date have been a source of recurring repeat demand So the pace at which we activate accounts is what gives us confidence in future revenue growth. On that measure, our progress is clear. At the time of our May 14th earnings call, we had 16 active commercial cancer centers. We ended the second quarter with 21 active commercial cancer centers, an increase of more than 30% in just one quarter. We remain on pace to meet or exceed our target of 36 active commercial cancer centers by year-end 2026. The majority of these paying customers are cancer centers that purchase RenovoCath are distinct from the clinical trial research sites participating in our Phase 3 TigerPak study. And our customer pipeline beyond those active centers is robust. In addition to our 21 active customers, we have 42 additional centers in various stages of evaluation, approval, and activation, representing a total of 63 centers in our commercial funnel. The growth of our total customer funnel is a 31% increase over the 48 centers we reported on our first quarter call. In addition, 15 of our TigerPack trial sites are positioned to move to commercial RenovoCAP use, and several have already begun doing so. As these sites transition, we expect them to be a meaningful contributor to our revenue in the second half of 2026. Another key metric of commercial success is repeat orders. We continue to see strong repeat ordering from our existing customers, which is one of the clearest indicators of physician satisfaction and product utility in interventional oncology. When a physician places a second, third, and fourth order for their Ovocath, it confirms their product is delivering an important treatment option and clinical utility for their patients. Given our customer pipeline and based on what we're seeing so far in terms of repeat orders, our third quarter revenue is tracking to exceed the second quarter and become yet another record revenue quarter. This commercial growth and strong customer pipeline are driven by a lean commercial team that is in place and executing. The results certainly speak for themselves. Going forward, we may incrementally add to our sales team where a specific market opportunity warrants it, but our growth model remains focused on efficient capital allocation and investing into our growth as needed. We are deploying the capital from our March capital raise prudently and effectively, and we are generating a strong return on that investment. We reduced our operating loss for the quarter, and as our revenue scales, we expect our operating loss will continue to decline. Physician-to-physician advocacy continues to grow, which is historically the most powerful driver of adoption in interventional oncology. Since receiving FDA 510 clearance, RenovoCath has been used in more than 900 successful procedures. Before I turn the call over to Ramtin, I want to take a moment to touch on the current overall pancreatic cancer market and how we believe this benefits us. There has been significant industry attention recently on new therapies for pancreatic cancer, and we believe those developments represent a meaningful opportunity for RenovoRx. Because RenovoCath is a device to deliver treatments more optimally, we see breakthroughs in pancreatic cancer therapy as complementary and as an important tailwind for our business. Beyond always putting the patient first for this deadly disease, I want to remind everyone that our TAMP technology enabled by RenovoCath is a collaborative, localized drug delivery platform with two ways emerging therapies can strengthen our opportunity. First, we can deliver established drugs locally, sequentially to or concurrently with novel therapies, creating the potential for improved patient outcomes, concentrating therapy where it is needed. Second, as new drugs come to market, we believe many of them can be delivered directly via a RenovoCath device. and in both cases, our view is that novel improved therapies make our targeted delivery platform even more valuable. We recently announced the first commercial clinical use of Rinovocast in sarcoma treatment, marking the expansion of our targeted drug delivery device to other solid tumors and showing real potential for expansion of localized delivery of chemotherapy. Ramtin will go into more detail about this milestone, but it's important to note that this expansion is physician driven. an important and encouraging element as we look toward the potential for broader adoption of RenovoCath. In closing, I could not be more proud of our team for their execution and hard work. The second quarter was a record quarter for us, not only from a revenue perspective, but also across all our key metrics, including growing customer pipeline, high retention rate, and repeat orders. With that, I'll turn the call over to our Chief Medical Officer, Executive Chair and Founder, Dr. Ramtin Agah.
Dr. Ramtin Agah
Chief Medical Officer, Executive Chair and Founder
Thank you, Shaun, and good afternoon, everyone. Before discussing the broader opportunity, let me briefly remind everyone of the science at the core of what we're building. Our patented trans-arterial microperfusion, or TAM, technology enables targeted therapeutic delivery across the arterial wall near the tumor site, designed to bait the target tumor while potentially minimizing a therapy's toxicity versus systemic intravenous therapy. For patients fighting solid tumor cancers while also managing the debilitating side effects of treatment, that difference matters. For decades, cancer care has rested on three pillars, surgery, radiation, systemic chemotherapy. We believe TAMP, enabled by RenovoCAP, represents a fourth option, one that is targeted, tolerable, and increasingly supported by a growing body of real-world clinical evidence. As Shaun mentioned, earlier this month, we announced the first commercial clinical use of RenovoCat in sarcoma treatment, showing the real-world potential beyond LAPC for expansion of localized delivery of chemotherapy. This first commercial sarcoma case marks an important milestone for RenovoRx, demonstrating RenovoCat's potential as a standalone device for treatment of other solid tumors beyond our core focus on locally advanced adenocarcinoma of the pancreas. This was a case where a physician who has treated LAPC using RenovoCat came back to RenovoRx with a plan to use our catheter to treat sarcoma, and we believe that this is a powerful endorsement of RenovoCat's potential. We believe targeted local arts delivery may offer advantages over systemic treatment for many other difficult-to-treat solid tumors. and we look forward to working with our Cancer Center customers to find new and broadening use of RenovoCat within its FDA-clear fields of use. In the second quarter of 2026, several scientific data updates supported the use of intra-arterial gem-septamine delivery via TAP in LAPC. A peer-reviewed case study by researchers at Moffitt Cancer Center, published in Radiology Case Reports, found that PET CT imaging, rather than CT alone, showed a meaningful reduction in tumor metabolic activity after treatment. These findings suggest that PET imaging may help optimize monitoring of therapeutic response following TAMP-delivered treatment. In addition, the PK sub-study of the TigerPAC trial has been accepted and soon to be published in the Journal of Cancer Chemotherapy and Pharmacology. The findings support TAMP as a targeted delivery method for gemseptabine, demonstrating its potential to increase local drug potency while reducing systemic exposure and common side effects. Finally, a peer-reviewed case series in case reports in oncology from researchers at Hackensack Meridian Health Jersey Shore University Medical Center was accepted and will be published in the near future. The case series highlights their experience with TAMP procedure in LAPC. The ramping up of publications of TAMP procedure by physicians, I believe, is another sign of adoption as TAMP traverses from an experimental procedure to becoming a standard of care. Earlier this week, we were pleased to announce that RenovoRx has achieved full enrollment in our phase three target pack trial for locally advanced pancreatic cancer. This significant milestone reflects years of patient recruitment, clinical execution, and collaboration among investigators and study team evaluating intra-arterial gemseptabine delivered through Renovo Rx's trans-arterial microperfusion or TAMP platform at Renovo CAT device as a novel drug device product candidate for difficult-to-treat LAPC. The primary endpoint of the study is overall survival. TargetPak is designed to evaluate whether Renovo Rx's patented method of targeted delivery of the chemotherapy, Gemseptibine, improves patient survival, safety, and tolerability compared to standard of care. Systemic intravenous chemotherapy, Gemseptibine plus Abraxas. On August 7th, target pack trial investigators were notified that patient enrollment is closing. Completion of the trial is expected during the first half of 2027 after 86 events have been observed. As of August 11th, 2026, 78 events have occurred. Following the completion of the trial, initial top line data is expected to be available during the back half of 2027. TIGERPAC is the cornerstone of our clinical development program, bringing us closer than ever in our effort to validate IAG and its efficacy through rigorous long-term evaluation. Completing enrollment in the Phase III TIGERPAC trial marks a major milestone for RenovoRx and our clinical program. With enrollment complete, we are now focused on advancing toward final data analysis. We believe TARGETPACK will provide meaningful additional validation of our TAMP therapy platform in an area with significant unmet need and limited therapeutic progress. The trial is designed to demonstrate the potential safety and superiority of intra-arterial gemseptamine delivered via LenovoCAT for locally advanced pancreatic cancer versus systemic IV chemotherapy, the current standard of care. I want to underscore a very important point. The transition of TIGERPAC sites is additive to our commercial expansion story, not separate from it. As Shaun noted, several of these sites have already begun moving to commercial renewable catalysts, and as more do, they join our growing network of active commercial cancer centers. This is an anticipated and meaningful contributor to our second half 2026 revenue. In parallel with TIGERPAC, we continue to build the evidence base for TAMP platform. Our post-marketing registry study is a multi-center study generating real-world safety and efficacy data in patients with solid tumors. We also continue to support investigated initiator trials, or IITs, in borderline resectable and metastatic pancreatic cancer, which are designed to achieve cost neutrality while broadening the platform's evidence base. In the second quarter of 2026, we began supporting a new IIT study for cholangiocarcinoma of bile duct cancer, which is in process to begin soon. Clinical data builds physician confidence. Physician confidence drives adoption, and adoption drives revenue. Commercial traction is now the foreground of the Renovo Rx's story, and our target pack clinical trial is important background. We are a scaling commercial business today, not a binary event vet. At the same time, the trial remains a significant long-term value driver, and a positive Phase III readout would have meaningful positive implications for physician adoption and reimbursement. Once we reach breakeven, we believe RenovoRx can be a profitable, high-margin, low-overhead, cash-generating business, a rare profile in our space. Thank you for your interest in RenovoRx. I will turn the call over to our Chief Financial Officer, Mark Voll.
Mark Voll
Chief Financial Officer
Thank you, Ramtin, and good afternoon, everyone. The second quarter was a strong quarter for RenovoRx, and the financial results reflect meaningful progress on our commercial plan. Let me walk you through the numbers. For the second quarter ended June 30, 2026, RenovoRx reported record revenue of $909,000, our strongest quarter to date. That is approximately 61% growth versus first quarter revenue of $563,000 and approximately 115% growth versus $422,000 in the second quarter of 2025. This growth was driven by continued active commercial center expansion and repeat ordering from our existing customer base. Gross profit for the second quarter was $766,000, representing a gross margin of approximately 84%, consistent with our roughly 85% gross margin we reported in the first quarter and reflecting the strong underlying economics of Renovo CAS. Research and development expenses for the second quarter were approximately $1.2 million, reflecting our continued investment in the Phase III TigerPAC trial, our post-marketing registered study, and our investigator-initiated trial program. Selling, general, and administrative expenses were approximately $2.9 million, reflecting the disciplined investment we have made to build and support our commercial infrastructure. Loss from operations for the quarter was approximately $3.4 million. and the Board of Directors of the Board of Directors of the Board of Directors per share improved to $0.06 compared to a loss of $0.08 in the second quarter of 2025 and a loss of $0.09 in the prior quarter. As of June 30, 2026, Renovo RX had approximately $9.5 million in cash and cash equivalents compared with approximately $12.4 million at March 31, 2026. This change aligns with our internal forecast and reflects the disciplined deployment of capital we raised in March. Importantly, assuming our revenue scales are who we anticipate, our active site count grows, our cash burden will continue to decline. We believe our cash position provides sufficient runway to fund operations into the second half of 2027 as we continue to work towards our goal of cash flow positive operations. We will be opportunistic if capital market conditions are favorable, but raising capital is not our focus today. Our priority is revenue generation and execution. Management believes that reaching a quarterly revenue run rate of approximately $5 million would position Renovo Rx at cash flow break-even. Based on our current trajectory, Our internal plan anticipates achieving breakeven operations in the fourth quarter of 2027, and we expect to make steady progress towards that run rate as our active site count scales towards and beyond our year-end target of 36 centers. Reflecting on our strong first half performance, we are raising and tightening the range of our full year 2026 revenue guidance to a range of $3.75 to $4.25 million from our prior range of $3 million to $4 million. This increase reflects our confidence in continued revenue scaling in the second half of this year. This new guidance implies year-over-year growth of 241% to 286% in 2026 compared to revenue $1.1 million in 2025. Beyond revenue, our primary commercial KPI remains active commercial center count. We're at 21 active commercial centers at quarter end that are targeting 36 or more by year end. As TigerPak sites continue to transition to commercial use in the second half of this year, We expect that activity contribute meaningful to revenue. Executing within our guidance range keeps us on the path we have laid out towards cash flow positive operations. Thank you. I'll turn the call back to the operator for Q&A.
Conference Call Moderator
Moderator
Thank you. We will now begin the question and answer session.
Conference Call Operator
Operator
If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Conference Call Moderator
Moderator
One moment please while we poll for questions. Our first question is from Justin Walsh with Jones Trading.
Conference Call Operator
Operator
Please proceed with your question.
Justin Walsh
Analyst at Jones Trading
Hi. Thanks for taking the questions. I was wondering if you could provide additional color on what prompted the physician to use TAMP and Renovocath in that particular sarcoma patient.
Shaun Bagai
Chief Executive Officer
Justin, thanks for the question. So as we've been talking about, the utility of this technology to reach more tumors is out there. This is a physician who's gotten comfortable with treating pancreatic cancers specifically and based on that he saw a case where there's a difficult to reach sarcoma tumor. These are challenging cases in general and with that he thought this would be a great opportunity to be able to utilize Renovocat to isolate flow and really get good tumor penetration of the drug. So it's what we expect. Radiologists are quite inventive in terms of physicians given that they work across the entire body and and as we've been told by many doctors is once we get this in their hands, they will see themselves getting in positions where they can utilize this with other tumors and other patients. I believe the beginning of adoption across the spectrum in several areas and it's great to see they took the opportunity here to help one of those patients with our technology.
Justin Walsh
Analyst at Jones Trading
Great, thanks. And one more question for me. I'm wondering if you can expand on how learnings from activating the first set of commercial centers can help facilitate your efforts to convert the additional centers from your pipeline?
Shaun Bagai
Chief Executive Officer
That's a great question, Justin. That's one of the reasons we didn't hire a big sales force last year is to really understand what the sales cycle and sales process is. And we found that there are a lot of moving parts in terms of getting back approvals to be able to purchase the catheter. Also, in terms of referring patients and making sure that referring patients know that the technology is now available when it becomes available. and the radiologists are connected with those physicians as well. And so I think a lot of the learnings to accelerate that site activation and we've seen this is to ensure that we've got buy-in from multiple specialties, strong communication and a lot of touch points. Now having a field force in the field and constant communication and showing up on site is really helping drive that. So that was important to have that focus with a small dedicated sales force versus going out to look at a partnership this early stage in market development to ensure that we actually get products on the shelves and then get referring physicians in with high touch points from our local reps. Our next question is from Charles Wallace with HC Wainwright.
Conference Call Operator
Operator
Please proceed with your question.
Charles Wallace
Analyst at HC Wainwright
Hi, thanks for taking my questions. First one from me. So congrats on finishing enrollment for the TIGERPAC study. So I was wondering, now that enrollment's closed, how many of the patients actually ended up randomized? I guess I'm asking if the full 114 patients were randomized at this point, or if the number actually fell above or below that.
Shaun Bagai
Chief Executive Officer
So we haven't yet completed randomization, so that's still in process. And we didn't report publicly the exact number, but we're very close in terms of complete randomization with a handful of patients left. And part of allowing the study to be open a little bit longer than June, like we anticipated, was to be able to have physicians enroll patients, have them in the induction phase. So if there are dropouts, we'd be able to randomize the 114th patient without issue. And we do have that buffer now. So we'll be pretty close to randomization completion here.
Charles Wallace
Analyst at HC Wainwright
Okay, that's very helpful. And then I guess on the site activation, now that you're at 21 active sites, it's, I think, a five gain from the first quarter. So what gives you confidence that you can reach the 36 centers by the end of the year? How many of these are from the clinical trial?
Shaun Bagai
Chief Executive Officer
So it's interesting. The 21 is as of the end of the quarter, so we've activated more since then, which we'll report out in the not-too-distant future. What gives us confidence is that we've got 42 additional centers that are in the process, so well over 36 total, with the bulk of the 15 TigerPak sites not yet treating commercially. A handful of those wanted to wait until enrollment's complete so they wouldn't have a competing interest from the physicians. So we anticipate starting to activate those over the next quarter or two. So those should contribute meaningfully to the revenue. But the other 40 or so plus in the customer pipeline will also allow us to overachieve that 36 target for the end of the year.
Charles Wallace
Analyst at HC Wainwright
That's helpful. And I guess on those, another follow-up on that. So on the clinical trial sites that become active commercial sites, What's your anticipation of the timeline from when they're activated to when they order?
Shaun Bagai
Chief Executive Officer
Actually, that's a great point, Charles, and good clarification. So when we say active, these are actually they've already purchased the catheter and treated the patient. So what we didn't want to do is start looking at sites that either are ready to go or have not purchased the device yet. So when we say active, these are actually purchasing using customers. and the other 42 in the pipeline could be somewhere along the process, including being greenlit to order, may have ordered already, but haven't treated their first patient. So they're real active commercial sites.
Charles Wallace
Analyst at HC Wainwright
Great.
Unknown Participant
Participant
Thanks, Shaun, for answering all my questions. Good question. Thanks, Charles.
Conference Call Moderator
Moderator
Our next question is from Ed Wu from Ascident.
Conference Call Operator
Operator
Excuse me. Acedient Capital Markets. Please proceed with your question.
Ed Wu
Analyst at Acedient Capital Markets
Sure, that's close enough. I want to congratulate you guys on all the progress on both front. My question is, as you guys scale up the volume for the Renewable Cap, do you think your margins can go higher, gross margin, operating margin, as you guys scale up in volume?
Mark Voll
Chief Financial Officer
Yeah, good question. And I think we have the opportunity to do that when we get to our next generation product, which we'll introduce sometime next year. And I think that will allow us to increase the gross margins of our current level.
Ed Wu
Analyst at Acedient Capital Markets
Great. That sounds good. And then my second question is on these additional centers that you guys have in process. Is there any difference in terms of the volume or business potentials? with the first 21s that you have already activated? Are they much smaller? Are they the same size? You know, revenue potential for these additional centers beyond what you're going to, that you already have?
Shaun Bagai
Chief Executive Officer
Yeah, great question, Ed. You know, what's great to see is that the 21 is a good representation of this full spectrum. So, within those active centers, we have a couple of the high-volume centers, and we have some of the smaller community-based hospitals. So if you look at the heat map of about 200 target centers with the bulk of them being treated at a small number of centers, we haven't hit all the high-volume places yet. So there's a lot of opportunity here for revenue growth. Mark, if you want to maybe touch on the 200 a little bit more.
Mark Voll
Chief Financial Officer
Right. So when we look at the market, it's pretty concentrated. The top 10 advanced cancer centers represent about 25% of the market. while we're really targeting the larger ones, we're still looking at a broad range of active cancer centers to bring online. But again, getting the larger centers will give us the largest amount of revenue opportunity in those centers.
Ed Wu
Analyst at Acedient Capital Markets
Great. Well, it's good that you guys have very good representative samples in your 21 centers so far. I really appreciate you guys answering my questions and I wish you guys good luck.
Conference Call Moderator
Moderator
Thank you.
Shaun Bagai
Chief Executive Officer
So I believe that concludes the questions remaining. I want to thank everyone for joining and excited to have you along this journey as we really demonstrate progress and really, again, capitalizing on our three major missions that took place this last quarter in driving revenue, increasing our commercial centers, and now expanding the technology beyond pancreatic cancer. Looking forward to many great quarters ahead, and if you have questions, please do follow up.
Conference Call Moderator
Moderator
This concludes today's conference call. Thank you for your participation. You may now disconnect